The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis

Not Applicable

Completed

• Conditions: Peri-implantitis
• Interventions: Other: Placebo; Other: Probiotic - BioGaia

• Registration Number: NCT02520401
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Detailed Description

This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Study design: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind randomized, placebo controlled clinical trial. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.

Selection of the study population: Adults, who consult at the departement of Periodontology at the University Hospital Leuven, with peri-implantitis and who fit the inclusion criteria will be asked to participate in this study.

Study Timeline

• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-08-06
• Study First Posted: 2015-08-11
• Study Start: 2015-10
• Status Verified: 2018-01
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• >18 years of age
• Patients with at least one implant* diagnosed with initial peri-implantitis.
• Willing and able to give written informed consent
• No signs of acute periodontitis
• presence of keratinized tissue around treated implant(s)

Exclusion Criteria

• patients who smoke
• patients with periodontitis
• pregnant or lactating woman
• patients with poorly controlled diabetes
• patients taking bisphosphonate mediation
• patient who had taken systemic antibiotics 3 months prior to treatment
• peri-implantitis treatment 12 months prior intake

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Control tablet
Test	Probiotic - BioGaia	Probiotic tablet

Primary Outcome Measures

Name	Time	Method
Probing Pocket Depth (PPD) at peri-implantitis sites	Baseline - 6 months	Pocket probing depth measured with Merrit-B probe

Secondary Outcome Measures

Name	Time	Method
Bleeding on Probing (BoP) at peri-implantitis sites	Baseline - 6 months	Binairy outcome: 0: no bleeding, 1: bleeding
Plaque at peri-implantitis sites	Baseline - 6 months	Binairy outcome: 0: no plaque, 1: plaque
Microbial samples	Baseline - 6 months	Of tongue coating, saliva and peri-implantitis site
Full mouth plaque score (FMPS)	Baseline - 6 months	Binairy outcome: 0: no plaque, 1: plaque

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium